Monday, July 31, 2006

What are some of the gravest threats that middle-school and high-school children face? According to a number of anti-smoking groups, one of the gravest of them all is on-screen smoking.

Yes - you read that correctly.

A coalition of anti-smoking groups - including the American Legacy Foundation, American Heart Association, and American Medical Association - is telling parents, in a new ScreenOutGuide, that:"On-screen smoking is one of the gravest threats that kids 10 and over will ever encounter."

The coalition is calling on parents to make their voices heard in Hollywood by urging the major movie corporations to get rid of smoking in movies - at least in movies that are seen by large numbers of kids.

According to the parent's guide, the simple act of getting smoking out of movies that kids see will save 60,000 lives per year:"Whether your own kids are in Grade 1 or Grade 12, you can help prevent as many as 60,000 future tobacco deaths a year by taking the survival steps outlined in this special SCREEN OUT! parent's guide."

The coalition asks parents to write to Time Warner, parent of Warner Brothers - one of the chief culprits of this "grave threat" - along with other major media corporations and ask them to keep smoking out of R-rated films.

The Rest of the Story

I challenge any one of these organizations to take one walk down any street in inner-city Boston and see if they still feel that the gravest threat to children ages 10 and up is on-screen smoking.

If you live in Roxbury or Dorchester, or in almost any major city in the country, it would be difficult to argue that on-screen smoking is the most pressing and gravest threat to children. Let's face it. These kids' very lives are at risk (and not 40 years down the road) just by walking outside in some of these neighborhoods. Violent crime in Boston, and many other cities, is an imminent and grave threat to just surviving one's adolescent years.

Add to that the problem of gangs, drugs, alcohol, and non-fatal youth violence and you've got some truly grave threats to our children.

To list on-screen smoking in movies as part of this list seems to me to undermine the seriousness of these other threats to the nation's youths and to show disrespect to communities where parents have to worry about whether their children will make it home alive if they venture out to a movie, much less about whether some actor lights up in a film.

Don't get me wrong. I'm not arguing that smoking is not a severe threat to the health of our children. But to pick such a narrow aspect of the smoking problem - on-screen smoking - and single it out as somehow representing the gravest threat to the nation's kids - is one of the most narrow-minded, misleading, and disrespectful actions I've observed in the tobacco control movement.

The parent's guide states that "the scientific case is rock solid" to support its assertion that 60,000 lives would be saved if parents are successful in getting Hollywood to remove smoking from R-rated films. Nothing could be further from the truth. That supposed rock is full of holes. It's probably more accurate to say that "the scientific case is as solid as Swiss cheese."

As I have explained, there are a number of reasons why one cannot validly conclude that on-screen smoking causes 38% of youth smoking initiation, even given the studies which have shown an association between exposure to smoking in movies and smoking behavior.

For one thing, parents who allow their kids to go out and see the types of movies that contain a lot of smoking are quite different from the parents who are more restrictive about what they allow their kids to be exposed to. In addition, the kids who go out to movies often are different from those kids who choose not to go out to these types of movies very often. It is very difficult to control for these major differences between these populations, which could well explain why one group is more likely to smoke. It is quite possible that it is not smoking in movies, but some other factor - related to WHY a parent allows their kids to spend hours and hours out with their friends watching these types of movies rather than forcing them to be home or in more controlled settings - that is the actual cause of increased smoking among this group.

Another serious methodologic problem with these studies is that there is most likely a severe measurement bias. Parents who are controlling enough not to allow their kids to to out to the movies are probably more likely to be listening in to or monitoring the phone call in which their childrens' smoking status is ascertained. It has been demonstrated that kids are significantly less likely to admit that they smoke when they believe a parent may be monitoring the phone call. This effect would create the appearance that kids who see more smoking in movies are more likely to smoke when the real effect has more to do with parental factors.

Even if the smoking in movies were contributing to the initiation of smoking, it is far too premature to make definitive quantitative conclusions about the specific proportion of kids who start smoking because of smoking depictions in movies. These definitive quantitative conclusions are, after all, based on only a handful of studies. If our science were loose enough to be willing to make these kind of quantitative conclusions based on such limited studies, we would have long ago been told that drinking coffee kills thousands of Americans every year from cancer and that if we all only write to Maxwell House, we could save thousands of lives a year.

Moreover, it is extremely unlikely that these studies are measuring an exclusive effect of seeing smoking in movies. Movies are just one source of exposure to depictions of smoking and to the formation of attitudes and social norms regarding smoking. Movies most certainly do contribute to these attitudes and norms, but to suggest that movies are the only such factor or that these studies are measuring an isolated effect of smoking in movies, is ridiculous and certainly not scientifically sound.

And to top it all off, even if we were to accept that smoking in movies does cause 38% of smoking initiation, there is no evidence to suggest that simply requiring an R-rating of movies that depict smoking would reduce kids' exposure. What might happen instead is that parents will stop paying as much attention to the movie ratings and that kids may be more likely to go to R-rated movies. An action like this one could undermine the ratings system to the point that parents don't pay much attention to it anymore. I don't know if that would be the effect or not, but neither do these anti-smoking organizations know that it wouldn't occur. My point is that even if smoking in the movies is as bad as these groups are claiming, it is inappropriate and not scientifically sound to state that the R-rating will save 60,000 lives per year.

This is just another example of how the anti-smoking movement has become extremist in its perspective and its public communications. Everything gets stretched, distorted, and exaggerated to such an extreme that instead of smoking in movies being a significant problem that needs to be addressed, it is the most grave threat to the health of our nation's children that kills exactly 120,000 people each year. Instead of secondhand smoke being a significant threat to workers who are exposed to the toxins and carcinogens for 40+ hours per week, it is now such a severe hazard that even 30 minutes of exposure can cause heart disease or lung cancer. Instead of parents smoking around children being an important health issue that needs to be addressed, it is now the worst form of child abuse.

Distorting the science in this way isn't doing the tobacco control movement any favors. It may get newspaper headlines in the short run, but in the long run, it is going to cast us as a bunch of crazy fanatics and it is going to destroy our scientific credibility in the public's eye.

One other aspect of this story deserves mention. And that's the extreme hypocrisy.

The American Legacy Foundation is actually asking parents to write to Legacy's corporate partner - Time Warner - to demand that they act to solve this problem. How hypocritical is that? If the problem is so bad that Legacy needs to mount a public campaign to get parents to pressure Time Warner, then why doesn't Legacy simply exert pressure on Time Warner to stop "killing kids?" All Legacy has to do is threaten to rescind its corporate partnership if Time Warner doesn't immediately eliminate smoking in non-R movies, and Legacy will have accomplished overnight more than thousands of letters from parents could accomplish in months.

Moreover, it seems disingenuouss for Legacy to deceive parents by not revealing their partnership with the chief culprit of the problem. How can they put out such a 'feel-good' pamphlet to parents, blasting Time Warner and talking about everything that must be done to confront these child killers, but not mention to parents the minor fact that Legacy and Time Warner are partners, and that Legacy calls Time Warner a "leader" in the tobacco control movement?

The rest of the story is that the anti-smoking movement has become plagued by the problem of extremism, which has played out through a destruction of our scientific integrity, repeated exaggeration and distortion of science, a complete lack of perspective, extreme hypocrisy, and a lack of integrity.

Perhaps parents who receive the "parent's guide" would do well to write an additional set of letters - these to the anti-smoking groups who put out the ScreenOutGuide, and suggest that maybe, just maybe, they have lost a bit of perspective if they truly believe that on-screen smoking is one of the gravest threats faced by our nation's children.

An article published this week in Brandweek highlights the Debunkify campaign being run by the Ohio Tobacco Use Prevention and Control Foundation to try to correct misperceptions about smoking and the health effects of secondhand smoke.

According to the article: "The Ohio Tobacco Use Prevention and Control Foundation and its 'stand' marketing campaign will roll out by September the mobile version of its 'Debunkify' effort. ... In keeping Debunkify 's tagline 'Kill the myths, before they kill you' the van crew will try to correct misperceptions like Ohioans' overestimation about the number of smokers and the underestimation about the deadliness of second-hand smoke. Those two notions were discovered from foundation focus groups and case study findings."

The Debunkify website introduces itself as follows: "The load of garbage you've been made to swallow over the years has put you and everyone you know at risk, and it's time we all did something about it. Most of what you think you know about tobacco use is just plain wrong. Myths, pure and simple. Bunk. So toss off your blinders, yank out your ear plugs, strip off your denial and prepare to be DEBUNKIFIED."

The Rest of the Story

I think it's a wonderful idea to debunk myths that have been spread among the public about the health risks of smoking and secondhand smoke, especially those that have been propagated by various groups like tobacco companies through their public communications.

There's just one problem here though.

If the Ohio Tobacco Use Prevention and Control Foundation truly wants to debunk the myths that are being spread around Ohio by various organizations about the health effects of secondhand smoke, then in addition to any myths R.J. Reynolds might be spreading, the Foundation should also debunk the myths that an Ohio anti-smoking group - SmokeFreeOhio - is spreading as well.

Myths about secondhand smoke appear to be an equal opportunity phenomenon in Ohio. Apparently, they can be spread just as easily by anti-smoking groups as by Big Tobacco.

Case in point is SmokeFreeOhio, which continues to spread myths about the acute cardiovascular health effects of secondhand smoke even though they were notified months ago that these claims were scientifically unsupported.

Rather than respond to my concerns in a scientific manner and defend its statements by citing the scientific evidence that 30 minutes of secondhand smoke exposure can cause hardening of the arteries, one member of the organization recently resorted to an ad hominem attack, publicly calling my scientific analysis of this issue to be nothing but "blather."

By the way, I'm not bothered by having my commentary termed blather. My son suggests that all the time. What is bothersome is the fact that absolutely no scientific evidence is produced to support the contention that I am speaking nonsense (my son does a far better job). Thus, it becomes simply a baseless personal attack and lends further support to the growing perception that SmokeFreeOhio is not willing to back up its public statements, perhaps because they are unable to do so.

First, SmokeFreeOhio claims that 5 minutes of secondhand smoke exposure makes the heart work harder to pump blood because of narrowing of the aorta. There is no evidence, however, that acute exposure increases blood pressure. On the other hand, acute exposure is documented to increase cardiac output, meaning that the heart is able to pump more blood out to the body.

This fact debunks SmokeFreeOhio's second fallacious claim, that 20 minutes of secondhand smoke exposure reduces the ability of the heart to pump. There is simply no evidence that acute exposure decreases heart contractility or increases blood pressure, making it more difficult to pump blood. Again, what the evidence shows is that cardiac output increases, indicating that the heart is, if anything, "better able" to supply blood to the body.

The third fallacious claim is that 20 minutes of secondhand smoke puts a nonsmoker at elevated risk of a heart attack. There is no evidence that this is the case, and it is completely implausible that a 20-minute exposure could increase heart attack risk for anyone other than someone who already has severe existing coronary disease and is basically a "heart attack waiting to happen."

SmokeFreeOhio's fourth myth is that 30 minutes of secondhand smoke contributes to hardening of the arteries by narrowing arteries and restricting blood flow. This claim is simply implausible. It is not possible for a 30 minute exposure to cause atherosclerosis, because hardening of the arteries is a process that takes many years to develop. Thus, there is no risk of a nonsmoker developing hardening of the arteries from being exposed to secondhand smoke for just 30 minutes. Moreover, the scientific evidence shows that a 30 minute exposure does not reduce basal coronary blood flow; thus, arteries are not narrowed and blood flow is not restricted. It is simply the reserve flow that is restricted, but that is of no acute clinical significance (although it certainly is significant if a person were to be exposed day in and day out for many years).

The fifth big myth is that the changes in fat metabolism induced by 30 minutes of secondhand smoke could lead to heart attacks and strokes. This is preposterous. It takes years and years of exposure and years and years of changes in this fat metabolism before a person is at increased risk of heart attacks and strokes. Once again, if these changes occurred day in and day out for many years, then they would be very significant clinically. But a simple 30 minute exposure does not increase heart attack or stroke risk due to induced changes in lipid metabolism.

The sixth, and perhaps most egregious myth, is that a 2 hour exposure to secondhand smoke can cause fatal or catastrophic arrhythmias. This is simply false. There is no evidence that such an exposure poses any risk of a fatal or catastrophic arrhythmia. A 2 hour exposure has been found to reduce heart rate variability, but this is basically a measure of cardiac autonomic function, and it does not indicate that the individual is somehow at risk of dropping dead from an arrhythmia. If it were, then the researchers who conducted this study would be in jail now for knowingly and unduly putting the lives of their research subjects at risk.

I would hasten to add that if SmokeFreeOhio's myths were not myths, but were true, then there would be no excuse for not banning smoking completely and immediately. If exposed individuals' ability to pump blood was reduced by a brief secondhand smoke exposure and this exposure put them at significantly increased risk of hardening of the arteries, heart attack, stroke, and a catastrophic or fatal arrhythmia, then we would simply have to ban smoking. There's no risk of that magnitude that I'm aware of that society tolerates. If SmokeFreeOhio actually believes what it is claiming, then there is no excuse for SmokeFreeOhio not to be calling for a complete ban on smoking. It would be irresponsible of me as a public health practitioner if I did not call for a ban on a voluntary activity that people do that could kill other people in just 20 minutes of exposure to it.

This is not a pretty situation, because if SmokeFreeOhio does not believe what they are claiming, then they are lying to the public. And if they do believe what they are saying, then they have lost all scientific credibility and they are irresponsible for allowing people to remain exposed to this incredible hazard.

Based on the response I have received from the organization (mainly, a failure to correct its so-called "fact sheet" after months and months), it is difficult for me to come to any conclusion other than that the organization is making an intentional decision to exaggerate and distort the science in order to increase the emotional appeal of their communication. Perhaps with the threat of a competing ballot initiative and millions of dollars of R.J. Reynolds funding, they are worried that they need to be more dramatic in order to win.

However, in my view, by risking the scientific credibility of the entire anti-smoking movement , harming our scientific reputation, betraying the public's trust, and misleading the public, the battle is already being lost. And it's not only the public that's losing. It's all of us in tobacco control and it's the character, values, credibility, and reputation of the movement which are all harmed by our joining Big Tobacco in spreading myths.

We, like the tobacco companies, now need to have our own myths "debunkified."

Thursday, July 27, 2006

In response to an attempt by the North Platte police chief and a local anti-smoking group to pursue a new policy by which people who smoke in cars with children would be arrested and charged with child abuse, the Lincoln County Attorney has determined that there are no grounds for doing this.

According to the article: "Lincoln County Attorney Jeff Meyer said that based on Nebraska law, exposing minor children to second-hand smoke does not rise to the level of criminal behavior and advised North Platte police chief Martin Gutschenritter against making any arrests. ...

Meyer wrote that the Surgeon General's opinion specifically stated that exposure to second-hand smoke to a child in 'any' confined space is detrimental. He said if exposure in a car rose to the level of a criminal offense, then exposure in a house, building, camper or any other conceivable confined space would also be harmful. "There is not a Nebraska law that specifically recognizes the exposure of children to second-hand smoke as a criminal act," Meyer wrote. Meyer said to lump the act into the child abuse statute was problematic. He said while most studies conclude its harmful, he could find no study that suggested it was 'probable' that a child's health would suffer harms from exposure. Meyer wrote that history has examples of children who have been harmed and others who haven't after both being exposed. He said no mathematical formula exists to determine harm and it would be impossible to find a medical expert who could testify that the simple act of exposure to second-hand smoke would cause probable harm 'within a reasonable degree of medical certainty.' ... Meyer said he was unable to locate a single specific example of a prosecution for child abuse nationwide based solely on exposure to second-hand smoke. He said consultation with other prosecutors also turned up nothing. Meyer also wrote that courts have made child custody and visitation decisions based on the presence of second-hand smoke but that a check with the Nebraska Department of Health and Human Services failed to reveal a single case where a healthy child was removed from a home based on it."

The Rest of the Story

This is truly good news. It shows that those responsible for making sure that what government does is within the confines of the law can help to protect us, and especially our children, from the harm that some anti-smoking groups are threatening to do through their misguided and fanatical policy proposals.

The reasoning provided by the county attorney is similar to the argument I outlined in my earlier post. Essentially, he points to the difference between risk and harm. He notes that while secondhand smoke may increase the risk of certain diseases, it does not produce almost certain harm, and therefore is not to be confused with child abuse, as a number of anti-smoking groups and advocates are doing.

I find it unfortunate that it has come to this. Never did I think that we would need attorneys to save us from the overzealous and overly intrusive reach of anti-smoking groups into the lives of our families. Never did I think that anti-smoking groups would represent a threat of harm, rather than an institution to alleviate or prevent that harm.

But in their fanatical and narrow-minded efforts to reduce risk, some anti-smoking groups are supporting policies that would, in fact, do significant harm. At least for now, the law is protecting us.

According to the American Legacy Foundation, as quoted in a UPI article, the Time Warner company - owner of Warner Brothers - is killing people because it is the leading source of depictions of smoking in the movies that are seen by kids and Legacy has stated that depictions of smoking in the movies kill people.

Interestingly, Legacy's chief corporate partner - which it describes as a "leader" in the anti-smoking movement - is none other than Time Warner, which in Legacy's view is a corporate killer.

Thus, Legacy is partnering with a company that, by its own admission, is a corporate killer.

The Rest of the Story

While I obviously think that it is quite absurd to claim that depictions of smoking in movies are killing people, the fact that Legacy apparently feels this way yet has chosen to partner with the leading one of these corporate killers is, in my mind, quite despicable. How can a public health organization knowingly partner with a company it considers to be killing thousands of people?

That's not only hypocritical, but it's irresponsible and completely inappropriate. And to me, it demonstrates a lack of integrity.

When it makes a nice sound bite, Legacy is quick to condemn Time Warner for killing kids. But when it needs help advancing its cause, Legacy's tune changes and all of the sudden Time Warner is now a leading anti-tobacco organization.

I'm sorry, but you can't have it both ways. Time Warner can't be both a corporate killer of thousands of people each year from tobacco-related diseases and also a leader in the anti-smoking movement. That's an oxymoron if I have ever seen one.

Time Warner's corporate killing activities go beyond Warner Brothers depiction of smoking in movies. Just last week, Time Magazine - owned by the Time Inc. magazine division of the company - contained a huge 4-page spread offering a free sample of American Spirit "natural" cigarettes to any adult takers. So I guess Time Inc. also is in the business of selling death and killing people.

That makes it even more unconscionable that a public health organization would partner with this company and call it an important leader in the anti-smoking movement. If anything, the evidence linking magazine advertising to cigarette smoking is a heck of a lot stronger than that linking seeing someone smoking in a movie to starting to smoke cigarettes.

Don't get me wrong - I don't think that Time Warner is killing anyone. They are legally advertising products and need to do so to make money; they are also producing movies in which the artists have chosen, gratuitously or not, to include smoking.

But if you do think Time Warner is killing people, then the company is certainly not a leader in the anti-smoking movement and certainly not a worthy corporate partner.

I simply don't think that the American Legacy Foundation, with this kind of hypocritical behavior, can be taken seriously. They either need to rescind their corporate partnership with these killers, or else quit indicting smoking in movies as one of the greatest public health problems of our time.

Tuesday, July 25, 2006

You can add watching movies to the list of activities - like smoking, passive smoking, and bungee jumping - that can kill you. According to the American Legacy Foundation, thousands of people are killed each year from ... you guessed it ... watching movies.

A July 21 UPI article by Meghan O'Connell quotes the head of Legacy as stating that depictions of smoking in the movies are a significant killer. The article was discussing an initiative by a number of anti-smoking groups to try to get smoking out of movies seen by large numbers of children via requiring an R-rating for any movie that depicts smoking (other than in a historical context):

"Cheryl Healton, president of the American Legacy Foundation, said that this is not censorship because eliminating tobacco imagery in films would save lives. 'These depictions actually kill people,' she said."

Other anti-smoking researcher/advocates were not quite as alarming, but still portrayed smoking in movies as being one of the most important public health problems of our time.

"'There's nothing else, no other single thing, that can be done to reduce youth smoking in the United States and the world than getting smoking out of movies,' said Stan Glantz, professor of medicine at the University of California and founder of Smoke Free Movies. ... Glantz said that prohibiting smoking imagery in movies rated PG-13 and under, except when it would lead to historical inaccuracy or when negative health effects are clearly shown, could easily be accomplished and would eliminate an estimated 120,000 tobacco-related deaths each year."The Rest of the Story

This is getting a little ridiculous. First, we find out that 30 minutes of exposure to secondhand smoke can cause us to immediately develop hardening of the arteries and keel over from a heart attack. Now, we find out that simply watching someone smoking in a movie can be fatal.

I guess this explains why it happens so often that when I'm in a theater watching a movie and a character lights up, the guy next to me keels over in his seat and drops dead.

Perhaps what I don't understand is why you would just want to require an R-rating for a movie that is going to kill people. Wouldn't you want to simply ban smoking in the movies? After all, large numbers of our nation's children do, and will continue to, watch R-rated movies. How can we possibly allow this hazard, knowing that the depiction of smoking in these movies is going to result in the deaths of many of these kids, 120,000 of them a year to be exact?

Truly, you can't be serious. You can't tell me that smoking in movies is single-handedly responsible for 120,000 deaths per year. You can't tell me that if we simply banned all movies, all of the sudden, 120,000 fewer people would die each year (or even 40 years later, if you want to allow for the lag time it takes before smoking kills people).

While we're at it, I guess that depicting alcohol abuse in movies also is a killer. And what about the portrayal of reckless or dangerous driving, sedentary lifestyles, poor nutrition, or sun exposure? Aren't these movies also killing people?

How much longer do we think the public is going to take us seriously if we claim that the simple depiction of smoking in movies kills people? Are people not going to simply start dismissing our ridiculous and exaggerated health claims?

Since exposure to secondhand smoke is apparently much worse than active smoking (it takes only 30 minutes of exposure to cause heart disease, as opposed to about 20 years for active smoking), I shudder to think how deadly it is to watch a movie that depicts passive smoking. They'd have to supply a gurney with each container of popcorn.

Monday, July 24, 2006

You will find 5 new posts up today. I don't want any of them to be lost due to the multiple postings, so here is a brief summary:

The first piece highlights 1 of 2 op-eds of mine that were published yesterday. This one, which appeared in the St. Paul Pioneer Press, argues that the Surgeon General misrepresented the science in claiming that brief exposure to secondhand smoke causes heart disease and lung cancer.

The second piece highlights the 2nd of my 2 op-eds published Sunday. This one, which I co-authored with Dr. Alan Blum and appears in the Birmingham News, argues that the FDA tobacco legislation pending before Congress would give the tobacco industry special protections, at the behest of Philip Morris, to protect Big Tobacco at the expense of the public's health.

The third piece highlights a commentary by me and Dr. Blum in this week's issue of The Lancet, released Friday, which argues that Philip Morris' vigorous support for the proposed FDA legislation should lead anti-smoking groups to be skeptical about whether the legislation will protect the public's health rather than the largest tobacco company's profits, as claimed by the Campaign for Tobacco-Free Kids, which stands shoulder-to-shoulder with Philip Morris in promoting this legislation.

The fourth piece adds further commentary to my post of last Thursday arguing that it is premature for anti-smoking groups to be attacking former Associate Attorney General Robert McCallum of wrongdoing for his role in the DOJ tobacco litigation. Here, I argue that the $130 billion smoking cessation remedy he altered would serve as a strong incentive for the tobacco companies to commit future RICO violations, and therefore was not allowable under the law to begin with.

The fifth piece explains why it is so important for anti-smoking groups not to make premature, undocumented, unsubstantiated attacks against individuals - like Robert McCallum - and how the actions of groups like Americans for Nonsmokers' Rights and the Campaign for Tobacco-Free Kids have put us in the same company as the tobacco industry in terms of making unsubstantiated claims, thus undermining our credibility.

An op-ed column of mine published in Sunday's St. Paul Pioneer Press brings to public attention the Surgeon General's misrepresentation of the science in claiming that brief exposure to secondhand smoke causes heart disease and lung cancer.

In the piece, I argue that the Surgeon General's press release accompanying the landmark report on the effects of 'involuntary smoking' misrepresented the science in the report itself by claiming that: "Even brief exposure to secondhand smoke has immediate adverse effects on the cardiovascular system and increases risk for heart disease and lung cancer, the report says."

I argue that the report says no such thing and that such a claim is in fact scientifically implausible, because it takes more than just a brief exposure even for active smokers to develop heart disease or lung cancer. Moreover, there is simply no evidence that a brief exposure causes heart disease or lung cancer.

The crux of my argument is that: "While it's accurate to state that brief exposure to secondhand smoke has immediate adverse effects on the cardiovascular system (this is well documented in the report), to jump from these acute and transient physiologic changes in artery elasticity, coronary lining cell function, lipid metabolism, and platelet activity to the development of chronic arterial disease is more than just a leap of faith: it's a misrepresentation of the scientific evidence."

I argue: "It seems to me the truth is enough. We don't need to exaggerate or misrepresent the science in order to promote smoke-free environments. It's enough to just stick to the scientific facts. In my view, the misrepresentation of the findings of the report highlights an increasing tendency among tobacco control practitioners to exaggerate the science in order to promote our cause. I think we are risking losing credibility with the public, something which will hurt the public health cause far more than any transient gains to be obtained by scaring people about these hazards."

And I conclude: "As public health practitioners, it's too important for us to retain public trust to unduly scare people with inaccurate health claims. We should leave blowing smoke to the tobacco companies."

The Rest of the Story

The rest of the story has now been told. It is up to the public to decide whether the Surgeon General as well as a host of anti-smoking groups have been misleading them by misrepresenting the science of the acute cardiovascular health effects of secondhand smoke and whether these groups are to be trusted in the future to make accurate health claims.

Most importantly, it is up to the tobacco control groups themselves to decide how to respond. Do they correct the inaccurate and misleading misrepresentations of the science and apologize to the public for not communicating the truth, or do they now decide to intentionally deceive the public about the nature of the hazards of secondhand smoke?

An op-ed column by Michael Siegel (Rest of the Story author) and Dr. Alan Blum (Professor and Director of the University of Alabama Center for the Study of Tobacco and Society) published Sunday in the Birmingham News suggests that by supporting the proposed FDA tobacco legislation, the Campaign for Tobacco-Free Kids and other public health and anti-smoking groups are actually promoting special protections for the tobacco companies at the expense of protection of the public's health.

The main point made in the op-ed is that special provisions inserted into the bill, presumably in order to gain the support of Philip Morris, have the effect of ensuring that the most important decisions about the regulation of tobacco products are placed into the arena of politics, and not science.

For example, the bill includes a provision that gives Congress veto power over any significant proposed FDA tobacco regulations. This allows the tobacco companies to use their powerful influence in Congress to block, on purely political grounds, any science-based regulations that they do not like.

While the legislation is advertised by the Campaign for Tobacco-Free Kids as creating meaningful and effective regulation of tobacco products, the bill also precludes FDA from eliminating nicotine - recognized as the addictive component of cigarettes and smokeless tobacco - from these products. The bill places this important decision into the political, rather than the scientific arena.

Moreover, the legislation specifically authorizes, for the first time, the use of "reduced exposure" language for cigarettes and other tobacco products. This would open the doors to Philip Morris finally putting on the market its reduced exposure cigarette that it has already test-marketed. The only thing preventing this now is the threat of litigation if consumers claim that they were misled by this marketing (since it is completely unknown whether reduced exposure products actually reduce health risks). Unfortunately, the FDA legislation would grant the industry special protection by essentially immunizing them from consumer claims related to these reduced exposure products.

It is important to recognize that tobacco would become the only product regulated by FDA for which a special system of corporate protection is built into the regulatory system to protect industry profits. Thus, rather than end special protections for the industry, as the Campaign for Tobacco-Free Kids claims, the legislation would institutionalize special protections for the industry for the foreseeable future.

For these reasons, the op-ed calls the FDA legislation a "dream come true" for Philip Morris.

Siegel and Blum conclude: "this is the ultimate reason why Philip Morris is so anxious to get Congress to pass this legislation. By freezing the current cigarette market, which the company dominates, and stifling competition, the legislation would give the leading tobacco company a virtual monopoly. Add to that the ability to market so-called 'reduced exposure' products without the threat of litigation for any false claims, along with the ability to appeal to Congress any time it doesn't like a regulation that the FDA proposes, and the result is a bill that's a dream come true for Philip Morris. The company can claim that it is supporting a strong public health measure but in reality it would retain special protection, ensuring that politics and profit, not science, will continue to be the final arbiter of the single most preventable cause of death and disease in our society."

The Rest of the Story

Perhaps the key point that Dr. Blum and I make is that if you actually read the legislation (rather than just accept the Campaign for Tobacco-Free Kids' propaganda regarding the bill), you will find out that "the bill defers to politicians, not medical and public health authorities, as the ultimate decision-makers for reducing the harm from tobacco."

This is an unacceptable concession to Philip Morris and serves to provide Big Tobacco with special protections, not enjoyed by manufacturers of any other products regulated by FDA, that protect corporate profits at the expense of protecting the public's health.

A commentary in this week's issue of The Lancet, written by Michael Siegel and Dr. Alan Blum (Director, University of Alabama Center for the Study of Tobacco and Society), questions the wisdom of anti-smoking groups lobbying for legislation, supported by Philip Morris, that would give the Food and Drug Administration (FDA) limited jurisdiction over the regulation of tobacco products (see: Siegel M, Blum A. FDA regulation of tobacco: reprieve for the Marlboro man? The Lancet 2006; 368:266-268).

The commentary suggests that the very fact this legislation is supported by Philip Morris should cause anti-smoking groups to be skeptical about whether it can really be the case that this bill would protect the public's health at the expense of tobacco industry profits. Our premise is that given Philip Morris' support, the bill deserves tremendous scrutiny. And sure enough, upon a careful analysis of the fine points of the bill, it becomes apparent that the legislation contains a large number of loopholes, inserted specifically to appease Philip Morris and protect its profits, that compromise the ability of the legislation to protect the public's health.

Foremost among these loopholes is a provision that essentially gives Congress veto power over any major regulations that FDA might promulgate. Congress would have 60 days to overturn, based solely on political grounds, most major FDA tobacco regulations. This ensures that the most important decisions made regarding the regulation of tobacco are made not based on scientific and policy concerns, but based on political ones. It ensures that the tobacco companies retain their ability to use their strong influence in Congress to block any meaningful regulatory action that could truly make a difference in protecting the public's health.

We also point out a number of other loopholes and absurdities in the legislation. For example: "the bill bans the use of strawberry, grape, chocolate, or similar flavouring additives in cigarettes but does not require the FDA to eliminate (or even reduce the levels of) toxic gases, including hydrogen cyanide or the more than 40 known cancer-causing constituents of cigarette smoke such as benz(a)pyrene, benzene, and radioactive polonium. The Agency would be given the authority to take such action but, unlike for the flavourings, there is no mandate that the FDA do anything to regulate these toxins."

One has to question the wisdom of a regulatory approach that takes stringent action to regulate the harmless components of this product - chocolate, grape, and strawberry - but requires no action on the toxic components - like hydrogen cyanide, benzene, or radioactive polonium. Are anti-smoking groups really protecting the public's health by being able to tell them: "We have made sure that you will not be exposed to any chocolate, grape, or strawberry. Unfortunately, you still may be exposed to more than 40 carcinogens. So sorry about that."

We also point out that there is no evidence that the performance standards allowed by the bill would do anything to protect the public's health: "[while] the bill stringently regulates new cigarette products, existing products will [merely] be subject to performance standards that would allow the FDA to require reduction or elimination of certain constituents in the tobacco smoke. However, it is not known which of the many chemicals in cigarette smoke, at what levels, and in what combination, are responsible for the observed pulmonary, cardiovascular, and carcinogenic effects of tobacco products." Thus, there is no guarantee that any required changes would protect anyone, and there is even the possibility that required changes could make cigarettes more hazardous.

In response, a Campaign for Tobacco-Free Kids commentary fails to address any of the above concerns.

The Rest of the Story

What became clear to me from this experience is that trying to discuss policy issues with the Campaign for Tobacco-Free Kids is like arguing with a brick wall.

It would have been nice if the Campaign had defended its support of the legislation by refuting, or otherwise addressing any of the specific concerns outlined above. Why does the bill grant veto power to Congress? How can the bill possibly require FDA to eliminate the grape flavor from cigarettes, but not the hydrogen cyanide? What evidence is there that performance standards will actually improve the public's health, since we don't know what specific constituents and in what combination are responsible for what diseases? And what is the public health merit of tying FDA's hands in a host of other ways, each ensuring that the most important decisions regarding regulation of tobacco products will be left in the realm of politics, rather than science?

If I were responding to my own commentary, I would have dealt point-by-point with the concerns expressed by myself and Dr. Blum. I think the public, and especially the tobacco control community, deserves an explanation as to why each of these specific concerns is unfounded. I think the Campaign, if it is going to put itself into the position of the representative of the public health community on this legislation (which I believe it has), has a responsibility to discuss and respond to these criticisms of the legislation.

Without a healthy discussion in the tobacco control and public health communities, I do not think that the Campaign has any business representing my (and our) interests in the halls of Congress.

And this response demonstrates that the Campaign is, in fact, about as responsive as a brick wall.

Apparently, the Campaign is unwilling to actually discuss the specific provisions of the legislation. Why?

Here is a hypothesis:

Maybe it's because they know that they can't win an argument over these specific provisions. Maybe they realize that these provisions are examples of compromises that were inserted in the bill specifically to protect the financial interests of Philip Morris at the expense of the public's health. Maybe it's because they realize that if they reveal the truth - that this bill resulted from a negotiation between Philip Morris and the Campaign - as the two primary interests represented at the negotiating table, the cat will be let out of the bag and it will become apparent that the Campaign has misled the entire tobacco control community, public health community, and the public. Maybe it's because it will become clear to us all that there is not, in fact, a public health justification for these provisions in the bill, and that essentially this legislation represents a behind-the-scenes, closed-door deal between the Campaign for Tobacco-Free Kids and Philip Morris that is not subject to real discussion, criticism, and revision.

Maybe, when it really comes down to it, it's because the public may become aware that the Campaign for Tobacco-Free Kids is really protecting the interests of Philip Morris at the expense of the public's health, helping to ensure that the nation's leading tobacco company receives special protections that no other manufacturer of a product regulated by the FDA enjoys (at least not in a way that is written into the law).

Perhaps because if the truth comes out, the public may realize that this organization might better be known as the Campaign for Tobacco Special Protections and Chocolate-Free Kids. After all, the bill does a fine job of keeping chocolate out of the tobacco smoke inhaled by children, but this wonderful public health gain comes at the expense of writing into law forever special protections for Big Tobacco stronger than anything Philip Morris could ever dream was possible.

Regardless of the true motivations of Associate Attorney General Robert McCallum in dictating that the DOJ tobacco trial team replace a proposed $130 billion backwards-looking smoking cessation remedy with a $10 billion partially forwards-looking one, one thing is quite clear: this action did not have the effect of undermining, weakening, or destroying the case, as anti-smoking groups have led the public to believe.

The reason? Because the $130 billion remedy is in direct conflict with the D.C. Appeals Court ruling that the only remedies allowable under the civil remedies provisions of the RICO statute are those which directly "prevent and restrain" future RICO violations. If they are not measured by future activity, designed to prevent future violations, and expected to be reasonably effective in preventing future violations, then they do not meet the statute's requirements, at least in the opinion of the Appeals Court.

What few people seem to realize (at least those within the tobacco control movement) is that the originally proposed $130 billion smoking cessation remedy is not only not allowable because it is backwards-looking (measured by past actions of the industry), but it is not allowable because it would not serve to prevent or restrain future RICO violations. In fact, I believe it would significantly increase the incentive for the tobacco company defendants to engage in future RICO violations in order to replace the customers they would lose from smoking cessation and to restore lost profits due to the payment of so much money.

By requiring the defendants to pay huge sums of money, the Court would be creating a strong incentive for the company to find some way to restore that money. And the most logical way to do that would be to recruit new smokers. This could be done most effectively by deceiving them about the health effects and addictiveness of cigarettes: in other words, through the very alleged RICO violations that the DOJ suit is aiming to address.

My own research has demonstrated that brand switching is simply not a prevalent enough phenomenon to allow tobacco companies to replace these huge sums of money. Less than 10% of smokers were found to switch cigarette brands in any given year and only about 5% switched to brands of another company.

Introducing new cigarette brands, especially reduced exposure brands, would be a second option to restore the lost funds. But absent the Philip Morris-supported FDA legislation pending in Congress, cigarette companies will not begin to market such products out of fear of potential litigation.

Thus, the only feasible option is to recoup the money by being more effective and more aggressive in recruiting new smokers, particularly young ones. In this way, the $130 billion "remedy" would actually serve as a strong incentive for companies to engage in RICO violations in the future.

There is simply no way I see that the originally proposed smoking cessation remedy could be defended as being allowable under the RICO statute, especially as that statute has been interpreted by the D.C. Court of Appeals.

This means that even if McCallum was blatantly trying to protect the tobacco companies under the direction of the Bush Administration, he was not effective in doing so. It means that contrary to the claims of anti-smoking groups, McCallum's actions did not undermine or in any way destroy the case, even if that was his intent.

As much as we in tobacco control might want to see huge sums of money awarded for smoking cessation and other anti-smoking programs, we have to work within the confines of the law. Accusing McCallum for destroying the case because it eliminates the possibility of receiving huge amounts of money for anti-smoking activities may be a headline-grabber, but it is misleading, based on a faulty understanding of the legal issues involved in the case, and unhelpful when it comes to actually protecting the public's health, as opposed to just talking about it.

In last Thursday's post, I discussed the legal issues involved in the remedies aspect of the DOJ tobacco case, explaining why the insistence of former Associate Attorney General Robert McCallum that the trial team substitute a $10 billion "partially forward-looking" remedy for a $130 billion "entirely backwards-looking" remedy did not in fact represent an undermining or destruction of the case, but actually a bit of a strengthening.

In my opinion, altering a remedy that had ZERO chance of being upheld by the D.C. Appeals Court could in no way have destroyed the case. If McCallum had really wanted to destroy the case, there are a lot of more effective things he could have done, including refusing to allow the trial team to appeal the appellate court decision to the U.S. Supreme Court.

In considering the discussion that this post provoked, I sense that the most important aspect of this issue has been lost. So I want to take this time to re-emphasize what I think is the real story here.

The real story is the importance of having solid documentation of wrongdoing before we in tobacco control make public accusations in which we malign the character of an individual, especially when we are issuing vicious, personal, political attacks.

I cannot read people's minds and so I cannot claim to have 100% definitive knowledge of whether McCallum acted appropriately or inappropriately. I could, possibly, be wrong in suggesting that the change in the requested remedy was motivated primarily by legal concerns related to the consistency of the proposed remedy with the appellate court's decision. But that's OK. I'm not accusing anyone of wrongdoing, so if my opinion turns out to be wrong, I can simply report the new findings if they come out and then join the anti-smoking groups in condemning McCallum. And I would be quick to do so and would do it in the strongest possible terms.

In contrast, the Campaign for Tobacco-Free Kids (TFK), Americans for Nonsmokers' Rights (ANR), and other anti-smoking groups that have attacked McCallum have made personal accusations against McCallum that could well destroy his career. These accusations, in fact, came very close to denying him the ambassadorship to Australia.

If it turns out that these groups are wrong, it is too late. There is nothing they could possibly do to repair the damage they have already done to this man's character.

Beyond the damage these groups have done to the character of an individual based on unsubstantiated and undocumented claims of wrongdoing, an equally important concern is the damage these groups have done to the tobacco control movement by putting us in the same category as the tobacco companies by virtue of our making widespread public claims that are unsubstantiated and undocumented.

We are quick to criticize the tobacco companies for making unsubstantiated claims. ANR has criticized the tobacco companies incessantly for claiming that smoking bans hurt restaurant sales when the evidence does not support that claim. TFK has criticized the tobacco companies incessantly for claiming or implying that low-tar and low-nicotine cigarettes are safer to health when the evidence does not support such a claim.

If we are to retain any credibility in criticizing tobacco companies for making undocumented claims, then is it not important that we not make undocumented claims of our own?

This is why I am particularly troubled by the behavior of some of the major anti-smoking groups in prematurely attacking McCallum, without adequate evidence that any wrongdoing took place (and in fact, in the presence of a DOJ investigation which concluded that there was no wrongdoing and that McCallum acted appropriately and with good judgment).

Could the DOJ investigation have been a complete farce? Could DOJ be completely covering up unethical behavior by McCallum? It's possible. It's certainly a theory. But the point is - there is absolutely no evidence, even at this late point in the game (the anti-smoking groups' attacks commenced more than a year ago and in one year, the only evidence that has been produced refutes their claims of wrongdoing) to support the anti-smoking groups' vicious (and now potentially defamatory) attacks.

In the wake of McCallum being cleared for involvement in the tobacco case by the DOJ Ethics Office and in the wake of his being cleared of any wrongdoing in the DOJ investigation, ANR is today proclaiming on its website that there is a "cancer on the Department of Justice" and that "the Justice Department, led by political appointees with tobacco ties [McCallum], ... [attempted] to torpedo the case in its final hours."

While I criticized ANR for putting this unwarranted political attack out without documentation at the time they put it up on their web site, certainly one would expect that given the fact that McCallum has been cleared, ANR would at very least remove this vicious attack from their web site now. Why can't they simply admit that they don't have the evidence to indict McCallum now and remove this propaganda until they have actual evidence, if it turns out that they are right?

To this day, ANR still has on its web site yet another attack on McCallum, which goes so far as to accuse him of ethical wrongdoing that warrants a claim being filed with the bar against him. Today, ANR states on its web site: "So, not only is there good reason to state that Mr. McCallum has been a tobacco industry lawyer, but there is sufficient reason for the Department of Justice to investigate his role in this case, and for an ethics complaint to be filed with the Federal Bar."

Well, the Department of Justice did investigate his role in the case, and they cleared him of any wrongdoing. How could there be sufficient reason for an ethics complaint to be filed with the Federal Bar when there is no evidence that he did anything wrong? And most disturbingly, how could ANR retain its misleading claim that McCallum "has been a tobacco industry lawyer" when they themselves admitted their mistake in using this terminology to characterize McCallum?

It's not just ANR which is misleading the public and prematurely attacking McCallum without adequate documentation of wrongdoing and in the presence of evidence that there was no wrongdoing.

To this day, the Campaign for Tobacco-Free Kids continues to tell the public that the change in the smoking cessation remedy from a $130 billion backwards-looking and therefore unallowable remedy to a $10 billion partially forwards-looking and therefore at least potentially allowable remedy: "was the direct result of efforts by Associate Attorney General Robert McCallum, a political appointee, pressuring the Justice Department lawyers to change their strategy and let the tobacco industry off the hook."

This is an unsubstantiated claim as so far, there is no documentation that McCallum was acting in order to "let the tobacco industry off the hook." As I have argued, even if he intended to do so, McCallum's actions would not in any way have "let the tobacco industry off the hook."

To make matters worse, the largest tobacco control list-serve has, without documentation of wrongdoing, informed literally thousands of tobacco control advocates and the public that Bush has "rewarded" McCallum for "rescuing" the tobacco industry.

Clearly, McCallum did not "rescue" the industry. He certainly did not hurt the tobacco case by tailoring the smoking cessation remedy and he certainly did not block the appeal of the Appeals Court decision to the Supreme Court. And there is no evidence that Bush is rewarding him for intervening politically in the DOJ case to protect the industry's interests. This is an unsubstantiated, and in my mind, misleading attack, accusation, and public statement.

The Rest of the Story

The rest of the story is that by making unsubstantiated and undocumented claims of political interference and ethical wrongdoing, we are acting in a manner little better than the tobacco industry, which we incessantly attack for making unsubstantiated health claims to the public. If we want to retain any credibility to levy such criticisms, then I think first we need to get our own house in order and cease making premature, undocumented attacks, especially ones which could well destroy the reputation and career of an individual.

Thursday, July 20, 2006

An Associated Press article published today on Examiner.com provides a glimpse into the reasoning being used by a former Justice Department trial lawyer who ran the government's tobacco litigation team and is now accusing former Associate General Robert McCallum of interfering in the case on behalf of the Bush Administration to undermine it and protect the financial interests of the tobacco company defendants by slashing the proposed smoking cessation remedy from $130 billion to $10 billion.

Recently, McCallum was cleared of any wrongdoing by the DOJ Ethics Office, which ruled that McCallum's "actions in seeking and directing changes in the remedies sought were not influenced by any political considerations, but rather were based on good faith efforts to obtain remedies from the district court that would be sustainable on appeal. Accordingly, we concluded that you did not engage in professional misconduct or exercise poor judgment."

Nevertheless, former DOJ tobacco litigation team leader Sharon Eubanks told The Age (Australia), in an exclusive interview, that McCallum "took 'aggressive actions' to destroy a multibillion-dollar fraud case against tobacco companies" and "undermined the case once it became apparent that prosecutors could win." Eubanks was reported to have stated that McCallum "took aggressive actions to destroy our efforts when it became clear that we had firm legal bases for seeking much more meaningful remedies from the court."

Today, some of Eubanks' reasoning to support her position was revealed in a Pete Yost (AP) article. According to that article, Eubanks' position is based on a contention that McCallum interfered in the case by insisting on a reduction in the government's proposed remedy from $130 billion to $10 billion. She apparently claims that "McCallum mischaracterized a court order in his statements to Capitol Hill, making it appear that U.S. District Judge Gladys Kessler criticized the government's embrace of smoking cessation as a remedy in the lawsuit."

The article explains that: "In his comments to the Senate, McCallum noted an order from the judge that the appeals court ruling 'struck a body blow to the government's case.' Eubanks said the 'body blow' language had nothing to do with a smoking cessation remedy and 'to make that suggestion is misleading.'"

Eubanks also complained that political appointees at DOJ wrote her closing arguments for her, in which she made the request for the reduced smoking cessation remedy.

The Rest of the Story

What the rest of the story reveals is that Eubanks is plagued by a misconception of what the D.C. Court of Appeals ruled in disallowing the government's request for disgorgement of past tobacco industry profits as a remedy in this RICO-based litigation.

Somehow, Eubanks views the Appeals Court decision as only disallowing the disgorgement remedy, but not presenting any barriers to the $130 billion smoking cessation remedy.

However, what the appellate court ruled was not that somehow, the disgorgement remedy was inappropriate for some reason specific to disgorgement. Instead, it ruled that the disgorgement remedy was inconsistent with the RICO statute because that statute requires any remedy to be designed to prevent and restrain future RICO violations, not to punish or remedy past violations.

The language of the Appeals Court was quite clear: "Section 1964(a) provides jurisdiction to issue a variety of orders 'to prevent and restrain' RICO violations. This language indicates that the jurisdiction is limited to forward-looking remedies that are aimed at future violations. ... Disgorgement ... is a quintessentially backward-looking remedy focused on remedying the effects of past conduct to restore the status quo."

Without a doubt, the government's proposed $130 billion smoking cessation remedy was designed to punish the industry for, and remedy the effects of, past wrongdoing. The government had requested that the industry pay to provide smoking cessation programs to smokers who had already become victims of the industry's alleged RICO violations.

As I argued back in April 2005 (when the appellate court decision was first announced), such a program is not consistent with the appellate court's interpretation of the RICO statute because it represents a backwards-looking remedy that is measured by past wrongdoing and awarded without respect to whether future wrongdoing will take place.

Like disgorgement, the smoking cessation remedy "is measured by the amount of prior unlawful gains and is awarded without respect to whether the defendant will act unlawfully in the future. Thus it is both aimed at and measured by past conduct." These words, directly from the appellate court decision, indicate with little doubt that the $130 billion smoking cessation remedy was not allowable and would certainly not have passed legal muster with the appeals court.

I have no doubt that Judge Kessler was fully aware that the "body blow" that the appeals court dealt to the DOJ case was not merely a result of the striking down of disgorgement, but the fact that it also cast doubt on the legality of the other major monetary remedies being sought by the government. That she allowed the government to go ahead with these monetary requests anyway does not indicate that she was giving final approval to such remedies, only that she thought it most prudent to at least allow the government the opportunity to present its requests. But she cautioned DOJ, in the most clear terms, that she was surprised that the government did not seem to be paying much attention to the appellate court decision.

What the rest of the story reveals is that McCallum essentially was forced to intervene in the case and "take over" because the trial team was not able to, or for some other reason not inclined, to respond appropriately in the wake of the appellate court decision by modifying its remedies requests to be consistent with the Court's interpretation the civil remedies provisions of the RICO statute.

If anyone undermined the case, it was the trial team, by refusing to craft an effective set of remedies that could pass appellate court scrutiny and have any decent chance of being upheld upon appeal, even if Judge Kessler was not convinced that such remedies were inappropriate.

I wrote, back in April 2005, that "the Department of Justice should focus the remedies portion of its case on the following two remedies that I think are both consistent with section 1964(a) (and likely to withstand appeal) and likely to have substantial public health benefits in terms of reducing tobacco use and improving health:

requiring substantial changes in cigarette advertising and marketing, including measures to prevent the marketing of cigarettes to youths and to prevent certain deceptive aspects of the marketing, such as the potential health value of "light" and "low-tar" cigarettes; and

requiring substantial changes in cigarette labeling and packaging, including larger, stronger, and more graphic warning labels.

In fact, I think that barring an unexpected Supreme Court reversal of the Appeals Court's disgorgement ruling, the potential value of the DOJ case now rests upon how successful it is in bringing about substantial, meaningful changes in tobacco product advertising, marketing, labeling, and packaging, which could directly prevent the tobacco companies from engaging in most of the alleged RICO violations in the future."

In other words, it was clear to me that the monetary remedies were never going to see the light of day and that pursuing these multi-billion dollar remedies might look good in the public's (and anti-smoking groups') eyes, but from a legal perspective, it was wasted and misplaced effort. In the months between the appellate court decision and the end of the trial, the real effort should have been placed on crafting remedies that would be effective in preventing and restraining future RICO violations, not in trying to squeeze the maximum possible money out of the industry to fund all the pet tobacco control programs of anti-smoking groups.

To proceed with closing arguments in which the government asked for a remedy which was clearly viewed by the governing court as being inconsistent with the law would have been an embarrassment. McCallum needed to intervene in order to save some face and at least present a remedy with some small chance of seeing the light of day (I don't think that even the $10 billion remedy, which has some forward-looking components will pass appellate court scrutiny, but it's a heck of a lot better than the $130 billion remedy, which is entirely backwards-looking).

And at least, by altering the closing arguments, it is clear that DOJ had read the appellate court decision. Up until that point, it wasn't even clear that DOJ was aware of the decision.

This information leads me to question why it was that the trial team was so seemingly blind to the appellate court's ruling. It would seem to me that trial lawyers would want to scour through the appellate court's decision with a fine-tooth comb, bathing in its clear direction that it provided to strengthen their case. It's like being handed the key to the promised land with directions how to get there.

What the DOJ trial team did was basically ignore the directions and proceed on the path they had already been taking, even though they were clearly headed in the wrong direction.

I can't explain this. I suppose one possibility is that the trial team had developed close relationships with a number of the prominent anti-smoking groups and didn't want to disappoint these groups by throwing out the monetary remedies, which would possibly have heaped scorn upon them. Might the trial team have been concerned that they would have been attacked and accused of wrongdoing just like McCallum was?

Another possibility is that the trial team spent so much time devoted to the case that they became so passionate about the issue that it clouded their clear legal judgment. Perhaps they believed so strongly in the cause that they simply failed to see that the same reasoning which the Appeals Court used to disallow disgorgement would apply just as well to the monetary remedies.

In addition to Eubanks' failure to respond appropriately to the appellate court decision, I am criticizing what I see as an inability to consider an alternative viewpoint - the perspective that the legal strength of the case is dependent not upon the amount of money you ask for, but the strength of the legal arguments you make.

With the $130 billion remedy, the government didn't have a legal foot to stand on. With the $10 billion remedy, at least the government was standing on one foot.

What McCallum did was not undermine the case at all. What he did was strengthen the case by staving off a huge legal embarrassment for the Department and giving the government at least a sporting chance of walking away with some monetary remedy, albeit not as large as the anti-smoking groups would have liked.

Wednesday, July 19, 2006

The Rest of the Story is today announcing that it will offer a $100 prize (a donation to the organization) to the first anti-smoking group to correct its fallacious claims about the acute cardiovascular effects of secondhand smoke (as pointed out previously on this blog) and apologize to the public for misleading them about this important issue.

Why do I feel this is so important that I'm willing to provide money to promote it? Because the tobacco control movement desperately needs an exemplary model to follow right now. We need a group - even just one - to step up to the plate and demonstrate for all of us the importance of scientific integrity and the seriousness with which we must take our responsibility to accurately communicate health information to the public.

If one group does this, I think it will set a model for all others to follow.

We no longer have the tobacco industry as a watchdog to keep us honest. So we need to develop an internal mechanism to accomplish this. Valuing scientific integrity is the only way that I can think of to make this happen. And I think groups can learn by example. So I do believe that if one group demonstrates such a model, others will follow.

Incidentally, is it not mildly ironic that the American Legacy Foundation - which today proclaims that "nothing is more important than the truth," has repeatedly refused (example 1; example 2) to tell the whole truth in citing research that it alleges provides confirmation that its "truth" campaign has led to a substantial decline in youth smoking.

In reporting the results of this research, Legacy has twice failed to disclose that the senior author of this research is in fact the President and CEO of the American Legacy Foundation, a conflict of interest that the public has the right to know about.

After all, how likely is it that the head of Legacy would publish a paper showing that Legacy's "truth" campaign is ineffective (a conclusion which I have argued is the actual finding of that research)?

This obviously introduces a potential bias into the analysis, interpretation, and reporting of the research, one which is substantial enough so that I think the public has the right to know about it and the Legacy Foundation has a responsibility to disclose it. Note that the conflict of interest is disclosed in the actual paper itself. What I'm talking about is the reporting of that research in press releases on Legacy's web site.

Also, I'm not suggesting that there is any wrongdoing in having a conflict of interest such as this. It's quite common in medical and public health research, and it's not inappropriate. What is important, however, is that the conflict be disclosed in all reporting of the research. That is a standard ethical requirement which most universities, including my own Boston University Medical Center Conflict of Interest Advisory Committee (of which I am a member), adhere to. Whether this requirement is interpreted as applying to the reporting of results on a web site, as opposed to in a scientific form, is not clear. However, my opinion is that the conflict should be disclosed in any public reporting of the study results, and especially when the reporting of those results is for the specific purpose of self-promotion, as it was in the case of Legacy.

As a movement which is based more than anything on the principle of the truth and the premise that we are truthful and the tobacco industry has not been, I agree that there is nothing more important than being truthful - and this certainly holds for our public communications and our scientific and health claims.

Protecting kids does not justify not being truthful. The ends of protecting the public's health does not justify the means of being misleading or inaccurate in our communications in order to achieve that goal.

A number of anti-smoking groups have recently been made aware of their inaccurate statements. Hopefully, they will recognize and admit their error, correct it, and apologize to the public for providing them with this false information.

Tuesday, July 18, 2006

On MPBN's (Maine Public Broadcasting Network's) Maine Things Considered yesterday afternoon, Rest of the Story author Dr. Michael Siegel argued against proposed legislation to ban smoking in cars with children. Click here to listen to the segment.

The Rest of the Story

While proponents of this legislation may indicate that they do not support banning smoking in homes, they should. If the hazards to children from smoking in cars are so severe that government needs to intervene to regulate the health risks to which parents expose their children, then certainly the problem of secondhand smoke exposure in homes, where children spend many more hours, is even more important and children deserve protection.

Whether proponents support home smoking bans or not, the same reasoning that would justify car smoking bans also justifies home smoking bans, and even more strongly.

One point I made in the radio interview which was not aired was the possibility that this legislation could harm children's health by causing parents to roll up their windows while smoking in fear that the police may pull them over.

I doubt that any anti-smoking group will have the courage to oppose this legislation, even though it leads naturally to supporting legislation to ban smoking in homes.

If you live in Ohio, you might not want to venture out of your home, according to the health claims being made by a state anti-smoking group. According to the organization - the Ohio Tobacco Use Prevention and Control Foundation - brief exposure to secondhand smoke such as what you might inhale in a restaurant while eating dinner creates a serious and substantial risk of heart attacks.

The group was quoted in a Ohio News Network article last Friday as stating that: "Some people say maybe I'll get a heart attack in 20 years. No that's not the issue, you might get a heart attack later that evening. We need people to understand what the physiology is, what the impact of this substance is."

Since Ohio residents can easily be exposed to secondhand smoke almost anywhere - including outdoors (and especially if smoking is banned in restaurants, which will push many smokers out onto the streets) - it would clearly behoove Ohioans to remain safely in their homes, so they don't need to worry about having heart attacks.

The Rest of the Story

I'll tell you what the physiology is. The physiology is that 30 minutes of secondhand smoke exposure has been documented not to affect basal coronary artery blood flow in nonsmokers. Thus, it represents no acute threat of a cardiac event to any person who doesn't have serious existing coronary artery disease that is so severe that any small insult to the system could trigger a heart attack.

The physiology is that atherosclerosis is a process that takes years to develop. So for a person without severe existing coronary disease, a 30-minute exposure to secondhand smoke cannot possibly cause a heart attack. And even in such a person who is chronically exposed to smoking in restaurants, it will not cause a heart attack immediately. The risk will ensue years later.

While it is theoretically possible that a person with severe coronary artery disease could have a cardiac event triggered by an exposure to secondhand smoke, there is no documentation that this is the case or that it has ever occurred.

Clearly, these are scare tactics being used to sensationalize the science in order to stir up Ohio residents to support banning smoking in restaurants. While I support that goal, I do not support the misrepresentation of the science to achieve that goal.

Ohioans can be assured that going to a restaurant, even one that allows smoking, puts them no more at risk of a heart attack than any other activity they might engage in outside of their homes. Unless your coronary arteries are almost completely clogged already, you are not going to suffer a heart attack one night because you were exposed to smoke in a restaurant during dinner that evening.

Why one would want to try to scare people in this manner is beyond me. Why one would want to risk losing all credibility with the public with a smoking ban referendum on the line baffles me. Why the science, and the plain, unadulterated truth, is not sufficient for the Ohio anti-smoking groups, is mysterious to me.

Why do the anti-smoking advocates in Ohio have to take everything to an absurd extreme? What is wrong with simply communicating the significant hazards of secondhand smoke among those who are exposed chronically to high levels, such as those who work in bars and restaurants. Why is it necessary to suggest to the public that an otherwise healthy person walking into a restaurant for dinner may keel over from a heart attack that night because of exposure to smoke for an hour or two?

This quote might just take the award for "Fallacious Anti-Smoking Claim of the Year." Why? Because it purports to be communicated in the context of an organization that is an expert in the physiology of the acute cardiovascular effects of secondhand smoke. In other words, by bringing physiology into it, the organization makes it appear that it has some sort of expertise in this subject matter that people should listen to, despite what they might otherwise think.

What we need now, I think, is not for people to understand what the physiology is. First, I think we need the anti-smoking groups in Ohio to understand what the physiology is. Then we can worry about transmitting that information correctly and appropriately to the public.

Apparently in response to the way in which the Surgeon General's report on involuntary smoking was publicized, newspapers around the world are beginning to convey misleading and inaccurate information to the public about the relative harms of smoking compared to secondhand smoke - creating misperceptions that are likely to undermine the public's knowledge of the dangers of smoking.

This past Sunday, a Philipines newspaper (Sun.Star Baguio) published a column entitled "Secondhand smoke: As harmful as smoking itself."

The article highlights the Surgeon General's warning that no level of secondhand smoke is safe, in a way which appears to be consistent with the headline's proclamation that secondhand smoke is just as harmful as active smoking.

The article itself seems to be a reasonably accurate portrayal of the information contained in the Surgeon General's report. The headline, however, follows the sensationalistic lead set by the Surgeon General in misrepresenting the findings of his own report.

The Rest of the Story

This is precisely why it is so important for public health groups to accurately communicate health information to the media. The media are likely to sensationalize what we say to begin with - if we sensationalize it before it even gets to the media, the results are going to be a completely inaccurate communication of important information.

Here, the Surgeon General's sensationalistic communication about his own report, in which he apparently misrepresented its findings in order to try to heighten the emotional appeal of the science, has resulted in thousands of people being misled about the relative hazards of smoking compared to secondhand smoke.

If people actually believe that smoking is no more harmful than being exposed to drifting tobacco smoke, then we are certainly going to see a waning of the public's appreciation of the severity of smoking's risks to health. And research has documented that this change in the public's appreciation of the hazards of smoking will result in an increase in smoking.

In other words, the misrepresentation of the science by anti-smoking groups is going to result in an increase in smoking -- we are doing public health harm by sensationalizing and distorting the science.

This is not just an issue of scientific integrity (although I would hope that this alone would compel us to present the science as accurately as possible). This is also an issue of causing tangible public health harm by undermining people's perception of the seriousness of the health risks associated with active smoking.

While I certainly appreciate the need to educate the public about the potential harms of secondhand smoke exposure, I do not think it is worth doing so at the expense of distorting their perceptions about the potential harms of smoking. And it is certainly not worth causing more deaths by undermining years of anti-smoking efforts and using tactics that are going to increase smoking.

There's got to be a better way to proceed. I suggest that maybe the place to start is with the truth.

In reviewing the time course of the numerous fallacious health claims being made by anti-smoking groups, I have come to the conclusion that the time course of the deterioration of the quality of our scientific communications coincides perfectly with the relinquishing by the tobacco companies of their role in monitoring and holding us accountable for our statements about the health hazards of smoking and secondhand smoke.

It seems to me that a major change occurred in the tobacco industry at the start of this century. Between 2000 and 2002, the tobacco companies began to acknowledge, for the first time, that smoking is a cause of disease. Over the course of about a two-year period (from my recollection), the tobacco company websites progressed from no acknowledgment of the hazards of smoking to stating that public health authorities believe that smoking is harmful, to stating that smoking is harmful.

Coincident with this change was the implementation of the Master Settlement Agreement, by which the Tobacco Institute and Council for Tobacco Research were disbanded and the tobacco companies agreed to discontinue lobbying against certain types of public policies.

It seems to me that in concert with these two major events, there was some sort of decision on the part of the tobacco companies to discontinue their efforts to monitor and counteract anti-smoking groups' communications by bringing to task any group that made inaccurate statements. The companies appear to me to have basically relinquished that watchdog role that they had previously played.

It is the relinquishing of the tobacco companies' watchdog role that coincides perfectly with the appearance of misleading, inaccurate, and completely fallacious health claims by anti-smoking groups.

Apparently, the knowledge that the tobacco industry was watching us was enough to ensure that we were extremely careful in our public communications. Any errors, even small ones, might come back to haunt us because the tobacco companies might pick up on them and call us on it.

Now, however, it is quite clear that nobody is going to call our bluff. We can pretty much say anything that we want and get away with it. The only thing stopping us is our own integrity and our own conscience. There are basically no external limits to the extent we can go in communicating secondhand smoke hazards to the public. And we, as a movement, certainly are not imposing any internal limits.

This impression is also informed by my own experiences in tobacco control. Prior to about 2001 or so, I observed an extreme amount of care in anti-smoking groups preparing statements to be issued to the public. We were very careful to document and substantiated all of our health claims. It was almost as if we were writing a scientific paper and had to carefully reference every point we made. At times, I even thought that the perceived need to document everything was exaggerated. But there was this constant fear that the tobacco industry was watching and that if you went beyond the science, they were going to catch you and call you on it.

These days, it seems to me as if it's more of a contest to see what we can get away with. What is the most sensational claim we can make for which we can provide some level of documentation, even if that documentation doesn't really directly support the claim? We don't have to worry about the tobacco industry calling us on it anymore, so however we can best support our agenda, the better, regardless of the actual scientific validity. I have observed a drastic decline in the number of phone calls I receive asking me to review scientific statements that groups would like to make, but want to get an expert opinion first, before going public.

Now, as long as one other group or individual makes a claim, other groups in the movement seem perfectly willing to repeat it, regardless of its validity. All it takes is for one person or one group to make the most absurd claim that is perceived as propelling anti-smoking efforts and that statement - probably the exact language - will appear in the materials of anti-smoking groups around the country.

And there is no mechanism to check the spread of these claims. There is no way to reign in the groups in their zeal to deliver sensational statements about the hazards of secondhand smoke or the benefits of smoking bans to the public.

This, by the way, is why my own research is quickly becoming obsolete. What is the importance of my researching and carefully documenting the health hazards of secondhand smoke exposure, the levels of exposure among various groups, and the effects of smoke-free policies, if anti-smoking groups are going to go around claiming that people are going to have heart attacks at night if they eat at a restaurant that allows smoking for dinner and that smoking bans will reduce heart attacks by 40%?

The Rest of the Story

In my opinion, we need a strong tobacco industry in order to keep us honest and to serve as a watchdog to ensure that our scientific communications to the public are accurate.

As funny and ironic as that sounds, I believe it is true. At least based on my observations.

The key to our scientific accuracy is apparently having a tobacco industry that is closely watching us and calling us on mis-statements when we make them. That fear has now gone and it has basically turned into a free-for-all.

Now don't get me wrong. I'm not suggesting that all anti-smoking groups, or even a large proportion of them, are spreading misinformation. However, a large enough number of them are doing so such that the tobacco control movement's image, reputation, and credibility, as a whole, is tarnished. And since none of the others are apparently willing to express displeasure at the movement being tainted by these absurd public claims, we are all essentially going along with this, even though many of us know that it is not right.

In a strange way, perhaps relinquishing their watchdog role was the most brilliant thing that the tobacco companies could have done. By letting the anti-smoking groups loose, perhaps they knew that it was only a matter of time before these groups starting making such ridiculous claims that their credibility would eventually be shot.

Sometimes, I guess the best strategy is to let the opponent do damage, rather than preventing them from doing damage. In the long run, the greatest damage they do might be to themselves.

Monday, July 17, 2006

No fewer than 18 anti-smoking groups are publicly claiming that just a half hour of exposure to secondhand smoke causes damage to the heart of nonsmokers similar to the heart damage caused by active smoking.

Smoke-Free Houston: "Even half an hour of secondhand smoke exposure causes heart damage similar to that of habitual smokers."

Smoke Free Galveston: "Even half an hour of secondhand smoke exposure causes heart damage similar to that of habitual smokers."

SmokeFree City: "Even half an hour of secondhand smoke exposure causes heart damage similar to that of habitual smokers."Americans for Nonsmokers' Rights: "Even a half hour of secondhand smoke exposure causes heart damage similar to that of habitual smokers."

Washington State Department of Health: "As little as half an hour of secondhand smoke exposure can cause heart damage similar to that caused by habitual smoking according to a study published in the Journal of the American Medical Association (JAMA. 2001;286:436-441)."

Bucks County Tobacco Control Project: "According to the Journal of the American Medical Association, even a half hour of secondhand smoke exposure causes heart damage similar to that of habitual smokers."

The study that is being cited to back up these claims is the Otsuka et al. study published in JAMA in 2001, which reported that a 30-minute exposure to secondhand smoke impaired endothelial dysfunction, as measured by coronary artery flow reserve velocity, to the same degree in nonsmokers as observed in active smokers (see Otsuka R, Watanabe H, Hirata K, et al. Acute effects of passive smoking on the coronary circulation in healthy young adults. JAMA 2001; 286:436-441).

The problem is that endothelial dysfunction, as measured by coronary artery flow reserve velocity, is hardly a measure of what we would call heart damage. Typically, when we speak of heart damage in medicine we are talking about damage to the heart muscle, often caused by a heart attack, that decreases the ability of the heart to pump.

It is possible, for example, to have a very small heart attack that does not result in any significant heart damage. As a physician, you might tell such a patient that they did not suffer any heart damage. Obviously, on a cellular level, there was damage done. But we don't speak of that as being heart damage. When we speak of heart damage, we're really talking about clinically meaningful damage to the heart that translates into impaired function.

The decrease in coronary artery flow reserve velocity that was observed with a 30-minute secondhand smoke exposure was transient, and resulted in no clinically meaningful damage to the heart.

To claim that the study demonstrated heart damage equivalent to that seen in smokers is terribly misleading, if not an outright inaccurate use of the term heart damage as the phrase is typically used in medicine.

If you tell your physician that you have a medical history of having suffered heart damage, she will most likely assume that you've had a heart attack or some other dramatic cardiac event. She will almost assuredly not consider transient endothelial dysfunction, as might occur after a high-fat meal, to be within the realm of what you mean when you say that you have suffered heart damage.

Most importantly, I don't think that the public, upon hearing that they may suffer heart damage from an exposure, thinks that what is meant is that there may be transient physiologic changes that are of little or no consequence clinically to them. I think the public would naturally assume that the statement is talking about clinically meaningful damage to the heart.

To make matters worse, all but two of the claims imply that heart damage is automatic. The exposure causes heart damage; not can cause heart damage. So even though the results were observed in just a single study that placed subjects in an extremely smoky environment, these claims imply that any level of exposure to secondhand smoke is enough to cause the "heart damage."

I consider these claims to be irresponsible because they are misleading and wrong. But they are also irresponsible because I think they may actually cause damage. They may well undermine the public's appreciation of the cardiovascular health risks of active smoking.

You see - another way to state the same thing that these anti-smoking groups are claiming is:

"The heart damage caused by habitual smoking is no worse than that caused by just a half hour of secondhand smoke exposure."

This is, in fact, the claim that anti-smoking groups are making.

And you can see that such a claim is going to make people think that active smoking really isn't all that bad. After all, if the heart damage you'll suffer from active smoking is no worse than that which you'd suffer from breathing in a little drifting tobacco smoke for a half hour, then it really doesn't sound too bad.

Moreover, this message completely undermines the incentive to quit smoking. Why quit, when you will almost assuredly be exposed at some point to at least 30 minutes of secondhand smoke? Apparently, your risk of heart damage will be the same, so what point is there to quit smoking?

In fact, the claim makes it appear that secondhand smoke is far more hazardous than active smoking, because it takes only 30 minutes of secondhand smoke exposure to cause the same degree of heart damage as years and years of active smoking.

This is not only blatantly misleading, it is truly damaging to the very cause towards which these anti-smoking groups are supposed to be working.

The more I look, the worse and worse this problem of misleading and fallacious scientific claims by anti-smoking groups becomes. And the less and less the anti-smoking groups seem to care.

As much as I support workplace smoking bans, especially in bars and restaurants, I simply cannot go along with communicating misleading and inaccurate information to the public in order to support public policy.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 25 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.